JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer (STABLE-MATES)

• ClinicalTrials.gov Identifier: NCT02468024
• Recruitment Status: Recruiting
• First Posted: June 10, 2015
• Last Update Posted: February 13, 2023
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Robert Timmerman, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: June 1, 2015
• First Posted Date: June 10, 2015
• Last Update Posted Date: February 13, 2023
• Actual Study Start Date: July 2015
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2015)

overall survival [ Time Frame: 3 years ]

To test the hypothesis that the 3-year overall survival in high risk operable patients with Stage I NSCLC is greater in patient who undergo SAbR as compared to standard sublobar resection (SR).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2015)

• progression free survival [ Time Frame: 5 years ]
  survival at 5-years for Stage I NSCLC who undergo SR or SAbR.
• toxicity as assessed toxicity using the Common Toxicity Criteria [ Time Frame: 3 years ]
  toxicity using the Common Toxicity Criteria

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
• Official Title: JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial
• Brief Summary: To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Detailed Description

Stereotactic Ablative Radiotherapy has been shown in single institution phase II and matched cohort studies to be effective at controlling primary early lung cancer. Recent pooled analysis of both the STARS and ROSEL randomized trials comparing SABR versus lobectomy have shown a significantly improved 3-year survival with SABR, giving further impetus for successful completion of a randomized trial .

Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.Patients will be accrued and followed for a minimum of 2-years after treatment.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Surgery versus SAbR

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Non-Small Cell Lung Cancer

Intervention

• Procedure: Lung Surgery
  Sublobar Lung Resection
  Other Name: SR
• Radiation: Radiation therapy
  Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
  Other Name: SAbR

Study Arms

• Active Comparator: Arm 1 lung surgery
  Sublobar Resection (SR)
  Intervention: Procedure: Lung Surgery
• Experimental: Arm 2 radiation therapy
  Stereotactic Ablative Radiotherapy (SAbR)
  Intervention: Radiation: Radiation therapy

• Publications *: Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 12, 2018): 272
• Original Estimated Enrollment (submitted: June 5, 2015): 258
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age > 18 years.
• ECOG performance status (PS) 0, 1, or 2.
• Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. Those with ground glass opacities and <50% solid component will be excluded.
• The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization.
• Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT scan of the chest and upper abdomen performed within 180 days prior to randomization. Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms.
• All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy within 180 days of randomization.
• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection.
• Tumor located peripherally within the lung. NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See below. Patients with non-peripheral (central) tumors are NOT eligible.
• No evidence of distant metastases.
• Availability of pulmonary function tests (PFTs - spirometry, DLCO, +/- arterial blood gases) within 180 days prior to registration. Patients with tracheotomy, etc, who are physically unable to perform PFTs (and therefore cannot be tested for the Major criteria in 3.1.11 below) are potentially still eligible if a study credentialed thoracic surgeon documents that the patient's health characteristics would otherwise have been acceptable for eligibility as a high risk but nonetheless operable patient (in particular be eligible for sublobar resection).
• Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria

• Major Criteria

  • FEV1 ≤ 50% predicted (pre-bronchodilator value)
  • DLCO ≤ 50% predicted (pre-bronchodilator value)

• Minor Criteria

  • Age ≥75
  • FEV1 51-60% predicted (pre-bronchodilator value)
  • DLCO 51-60% predicted (pre-bronchodilator value)
  • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) as estimated by echocardiography or right heart catheterization
  • Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons. The belief must be declared and documented in the medical record prior to randomization.
  • Poor left ventricular function (defined as an ejection fraction of 40% or less)
  • Resting or Exercise Arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%
  • pCO2 > 45 mm Hg
  • Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3.
• No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor (e.g. previous lung cancer) on the ipsilateral side. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted.
• No prior lung resection on the ipsilateral side.
• Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Peri-menopausal women must be amenorrheic > 12 months prior to registration to be considered not of childbearing potential.
• No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• evidence of distant metastases
• prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. No prior lung resection on the ipsilateral side.
• pregnant and lactating women
• prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sarah Neufeld, MBA; 214-645-8525; sarah.hardee@UTSouthwestern.edu

• Listed Location Countries: Australia, Canada, United Kingdom, United States

Administrative Information

• NCT Number: NCT02468024
• Other Study ID Numbers: STU 022015-069
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Robert Timmerman, University of Texas Southwestern Medical Center
• Original Responsible Party: University of Texas Southwestern Medical Center
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Timmerman, MD; UTSW Medical Center

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: February 2023